Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002 (b)(6).The product was investigated in the laboratory of the manufacturer.A visual inspection was performed.The oxygenator was heavily clotted.The product was rinsed with water and cleaned with sodium hypochlorite solution.A tightness test according to lv 201 was performed and no leakage was detected hereby.Clotting is a known phenomenon to mcp and the cause of this incident was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator in question operated within mcp specifications.Thus the reported failure could not be confirmed.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.
|